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NOT YET RECRUITING
NCT05970068
NA

Hydrophobic Tubes for the Treament of Lower and Upper Limb Lymphedema

Sponsor: Universidade do Porto

View on ClinicalTrials.gov

Summary

Lymphedema is a chronic condition causing fluid buildup in affected limbs. Traditional treatments often fall short, but subcutaneous implantation of hydrophobic silicone tubes shows promise, creating artificial drainage pathways. This approach proved effective in managing obstructive lymphedema in lower limbs. Further research is needed to validate its efficacy and explore long-term outcomes.

Official title: Implantation of Hydrophobic Tubes for Edema Fluid Drainage in Obstructive Lymphedema of Limbs - a Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2023-12-15

Completion Date

2026-12-31

Last Updated

2023-11-01

Healthy Volunteers

No

Interventions

PROCEDURE

implantation of hydrophobic tubes for edema fluid drainage

1 - A 2-cm-long incision is made at the border of the hypogastrium or lumbar region 10 cm above the inguinal crease; 2- A 1.5-cm-wide and 100-cm-long metal tube tunneling device is introduced under the skin and bluntly passed in the subcutaneous tissue toward the thigh and internal aspect of the calf; 3- Incisions 2 cm long are made in the groin and calf, through which the tunneling device was passed; 4-The hydrophobic tube is passed upward through the tunneling device, after which the tunneling device is removed; 5-The upper and lower ends of the hydrophobic tubes are fixed to the fascia with absorbable sutures.

DEVICE

Best Medical Treatment

Compressive therapy, Phisioterapy, venous intervention

Locations (1)

Faculdade de Medicina da Universidade do Porto

Porto, Portugal